Finding studies
Finding studies
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Amy A Kirkham, PhD
CONTACT
Courtney R Chang, PhD
CONTACT
Lead
University of Toronto
With
This study will be a two-centre (University of Toronto and University of Alberta), two-arm, parallel-group, randomized controlled trial in older (60+ years) breast cancer survivors. Participants will be randomly allocated to one of two groups for 16-weeks: 1) time restricted eating group + protein counselling and healthy eating education (intervention group) or 2) healthy eating education (comparison group). To standardize the potential participant bias toward healthy lifestyle changes and pre-existing physical activity tracking devices (i.e., Fitbits are common in this demographic), all participants will receive Canada's Food Guide, the Canadian 24-h movement guidelines, and a Garmin smartwatch at baseline. To enhance recruitment and retention, and in consideration of ethics of denying care to patients with elevated CVD risk, study staff will provide both groups with standardized healthy eating education following material from Canada's Food Guide 'Resources for Health Professionals' which aligns with dietary patterns that improve cardiovascular health. The investigators will standardize the type and frequency of intervention support across both groups but with differences in content. Support will consist of an initial call and check-in calls at weeks 1, 3, 6, 12 and daily text messages to act as a reminder, self-monitoring tool, and collect adherence. After the 16-week intervention, no further formal study support will be provided for participants. Participants will be informed they can continue to follow the interventions to the extent they choose for the next 6 months and that the investigators will contact them for one final assessment around that time. In-person study visits will include a \~4.5-h comprehensive assessment at baseline and again at 16 weeks, and one abbreviated \~2-h assessment at 40 weeks as a 24-week follow-up.
Age
60–85
Sex
FEMALE
Healthy volunteers
Not accepted
